Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Cont

FDA device recall Z-0506-2026 · posted 2025-11-14 · Open, Classified

Recall details

Recalling firm

Thoratec LLC

Reason for recall

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Action taken

On 10/09/2025, the firm sent via email an "URGENT MEDICAL DEVICE RECALL (CORRECTION)" Letter to customers informing them that Abbott has observed an increase in customer complaints about the controller Backup Battery Fault Alarm. The issue is potentially due to excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller which results in corrosion of the ribbon cable connectors. What Customers should know: When the Backup Battery Fault Alarm is active, this Advisory alarm will appear as a flashing yellow wrench on the user interface and Call Hospital Contact; Backup Battery Fault will appear on the screen, accompanied by a slow beep tone. When in a clinical setting, the HeartMate Touch App will have an active alarm that reads Replace Backup Battery. As a reminder, when this alarm is active and the pump is running and flow is maintained (indicated by the green arrow symbol ), this alarm does not affect the controller or pump functionality. Customers are instructed: -When performing Backup Battery installation or replacement, clinicians should minimize excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller. An example of excessive handling would be using the ribbon cable to hold the weight of the controller. -Remind patients and caregivers to follow the Patient Handbook: If System Controller Backup Battery Fault Alarm is active, patients should first ensure that no other alarms are active, and then they should call their hospital contact as soon as possible for diagnosis and instructions. Patients and caregivers should not immediately attempt to exchange the System Controller without clinical guidance. For questions or further assistance is needed regarding the Backup Battery Alarm after following Instructions for Use, contact Abbott Technical Service at 1-800-456-1477 (Business hours: 8 AM EST to 7 PM EST).

Root cause

Device Design

Status

Open, Classified

Product code

DSQ

Quantity affected

35376

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA

Date initiated

2025-10-09

Date posted

2025-11-14

Location

Pleasanton, CA